Senior Scientist Analytical Development

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Job description

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VACANCY REFERENCE NUMBER 147026

Senior Scientist

Location: United States : Birmingham, AL

Function: Innovation Management (R&D)

Career Level: Experienced professionals (2-5 years)

Legal Entity: Evonik Nutrition & Care GmbH

Business Line: Health Care

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Click here to learn more about Evonik from our employees

The Senior Scientist Analytical Development will lead projects and project components pertaining to analytical aspects in the development of parenteral controlled release products including polymeric microparticles, polymeric and lipid nanoparticles, nanosuspensions, liposomes and similar drug products. The development may include aspects of method development, specification development and justification, method transfers, stability assessment, GLP characterization, and method qualifications in the highly regulated pharmaceutical industry. The Analytical Development team is primarily responsible for the development of clinically acceptable processes and methods through clinical trial phase of development. The team works closely with formulation development, quality assurance, quality control, EHS, engineering and manufacturing teams to ensure the successful development and commercialization of pharmaceutical products.

RESPONSIBILITIES

* Project Leadership and Execution of Tasks with increasing complexity and Projects in Analytical Development
* Leads smaller projects on analytical method development
* Plans and performs multi-part experiments and conducts more complex activities in support of pharmaceutical formulation research and development and/or manufacturing operations
* Proactively communicates with other functions regarding project and operation requirements, priorities, data analysis and results, issues and challenges, important observations as well as timelines
* Generates, analyzes data and results and contributes to the recommendations for next steps based on the data
* Leads or supports trouble shooting of methods and method optimization including root cause analysis, action plan, (Analytical) Quality by Design approach
* Contributes to research reports and summaries; supports writing of reports and summaries for projects of appropriate scope and complexity
* Communicates with clients, contributes to client communication presentation, explains results and analytical method development approach
* Applies appropriate regulatory guidance by considering development stages as well as internal and client requirements to ensure the successful progress of pharmaceutically acceptable products
* Recognizes and acts upon opportunities regarding the maintenance and improvement of Evonik's facilities, equipment, and procedures; takes corrective action as directed by management.
* Supports Safety and Quality improvements in the area (e.g. contributes/leads 5S program, SOP and process optimization, new systems evaluation etc.)
* Develops procedures/ processes/systems to outline how the group will execute on internally and externally funded projects
* Contributes to internal research and intellectual property projects and initiatives
* Coach junior scientists and lab techs on internal and external projects; Trains, coaches staff in data analysis and project execution
* Maintains current scientific knowledge through review of current scientific literature and the encouragement
* Proactively searches literature and regulatory guidance (ICH, FDA) to maintain awareness of current technology and regulations.
* As a role model, follows SOP's and enforces, coaches on following SOP's
* Maintains thorough and accurate research and laboratory documentation including experimental methods, observations, data, and results in support of SOP, cGMP, and GLP regulated activities
* Follows safety practices and procedures; uses personal protection equipment (PPE) appropriate to the type of hazard and exposure potential. Actively participates in identifying and resolving safety issues
* Effectively and efficiently moving parenteral and biomaterial products through Research and Development from early stage feasibility through lead candidate selection and finally commercialization
* Provide support for analytical development through the Product development cycle
* Procure equipment necessary for the successful analysis of products
* Continuously improve department and individuals within the department to meet best in class vision

REQUIREMENTS

* BS Degree in a Scientific field (chemistry preferred) with 5+ years of analytical experience, OR MS or PHD with a demonstrated level of experience as determined by management.
* Strong organizational experience
* HPLC experience
* Pharmaceutical experience would be preferred
* Having formulation experience would be a plus
* Microscopy, polymer characterization, spectroscopy, biology/biologics experience would be a plus

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at .

VACANCY REFERENCE NUMBER 147026

Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.